Italy vs. US: which forensic model works best for dual diagnosis offenders?
NCT ID NCT07585656
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 600 offenders with both mental illness and substance abuse in Italy and California over three years. Researchers will compare community-based care in Italy with high-security hospitals in the US to see which model leads to better outcomes, like reduced violence and improved mental health. The goal is to find the most effective ways to treat and rehabilitate this complex population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could point toward better treatment strategies for offenders with both mental illness and substance abuse, potentially reducing repeat offenses and improving rehabilitation.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not apply to other regions or populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult offenders with mental disorders recruited from forensic psychiatric care systems in Italy and California. Participants are enrolled at the time of the application of a security measure or upon admission to a forensic facility, including both custodial and non-custodial settings. In the Italian cohort, participants include individuals placed under security measures within the National Health Service, such as those admitted to REMS or managed in community-based forensic or psychiatric services. This group reflects the community-oriented Italian forensic model, characterized by rehabilitative pathways and integration with territorial mental health services. In the California cohort, participants are recruited from high-security forensic hospitals and community forensic programs under the Department of State Hospitals, including individuals deemed incompetent to stand trial (IST) or not guilty by reason of insanity (NGRI). This population reflects a h
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 18 years or older. * Individuals admitted to forensic psychiatric care in Italy or California. * Presence of a diagnosed mental disorder according to DSM-5 / ICD criteria. * Presence of a current or lifetime Substance Use Disorder, consistent with a dual-diagnosis condition. * Placement in one of the study settings: Italy: REMS or other forensic/community facilities under custodial or non-custodial security measures; California: Department of State Hospitals forensic facilities. * Ability to provide written informed consent, or consent provided through a legal guardian when applicable. * Availability for longitudinal follow-up at 12, 24, and 36 months. Exclusion Criteria: * Absence of a confirmed psychiatric disorder. * Absence of current or lifetime Substance Use Disorder. * Non-forensic psychiatric patients without criminal justice involvement. * Severe cognitive impairment or neurological condition preventing valid assessment. * Acute medical or psychiatric instability that makes participation temporarily impossible. * Inability to complete the assessment procedures, even with support or adapted administration. * Refusal to participate or withdrawal of informed consent. Insufficient clinical, forensic, or follow-up data for longitudinal analysis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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